The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.

Group 1: 18-70 years of age, non-diabetic with no nervous system disease (healthy control group)

Group 2: 18-70 years of age with Type I or Type II diabetes with significantly painful diabetic neuropathy (VAS > 40mm at Baseline)

Group 3: 18-70 years of age with Type I or Type II diabetes with non- painful or insignificantly painful diabetic neuropathy (VAS < 40mm at Baseline)

Exclusion Criteria:

History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator

Allergy to lidocaine

Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study

Women who are pregnant, breastfeeding or trying to become pregnant

History of slow-healing diabetic foot ulcers

Current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies

Subjects taking Class I antiarrhythmics

HgA1c > 11%

Active cancer within the previous two years except treated basal cell carcinoma of the skin

Co-morbidities that can produce neuropathy

Subjects taking sodium channel blockers within one week of study treatment and throughout the study

Subjects taking any other experimental drugs within 30 days prior to Screening Visit (Visit 1)

Application of lidocaine patch to either foot within two weeks of Screening Visit (Visit 1)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086150